FDA 510(k) Application Details - K072778

Device Classification Name	Needle, Acupuncture, Single Use   More FDA Info for this Device
510(K) Number	K072778
Device Name	Needle, Acupuncture, Single Use
Applicant	HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	YUKUO HSU Other 510(k) Applications for this Contact
Regulation Number	880.5580   More FDA Info for this Regulation Number
Classification Product Code	MQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2007
Decision Date	11/19/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review